Docket Management
Docket: 01D-0465 - Guidance for Industry on Major, Minor, and Telephone Amendments to Abbreviated NDAs
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. Gwen Welty Date/Time 2002-03-21 17:46:14
Organization Alcon Laboratories, Inc.
Category Company

Comments for FDA General
1. General Comments Regarding Docket Number 01D-0465: The December 2001 revision to Major, Minor and Telephone Amendments to Abbreviated New Drug Applications was an improvement in the guidance document. The main differences included: 1. The addition of supplements to the scope of the guideline was a beneficial one. This allows the Agency to use the telephone amendment for supplements which was previously an option reserved for new applications only. This should facilitate faster reviews for supplements since telephone amendments are reviewed upon receipt. 2. The removal of the fax amendment helped clarify the categories since the differences between a telephone amendment and a fax amendment were not clear to either the Agency or Industry. Thus, it appears that the fax amendment category was not used. This deletion was a much needed improvement. 3. The reasons to classify an amendment as Major have been revised to include an example list including those that require a new batch of drug product to be made, a new bioequivalence study or new analytical methods and full validation data. Other circumstances should get division level concurrence. The criteria in the previous revision of the guidance was based more on how long it took a chemistry reviewer to perform the review which was not very informative to Industry. This revision to the guideline should result in more amendments being classified as minor rather than major which results in a faster review clock (60 to 90 days rather than the 180 days for a major amendment). This is a definite improvement.

EC -1